Dataset Information

A Smartphone-Based Health Care Chatbot to Promote Self-Management of Chronic Pain (SELMA): Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Ongoing pain is one of the most common diseases and has major physical, psychological, social, and economic impacts. A mobile health intervention utilizing a fully automated text-based health care chatbot (TBHC) may offer an innovative way not only to deliver coping strategies and psychoeducation for pain management but also to build a working alliance between a participant and the TBHC. OBJECTIVE:The objectives of this study are twofold: (1) to describe the design and implementation to promote the chatbot painSELfMAnagement (SELMA), a 2-month smartphone-based cognitive behavior therapy (CBT) TBHC intervention for pain self-management in patients with ongoing or cyclic pain, and (2) to present findings from a pilot randomized controlled trial, in which effectiveness, influence of intention to change behavior, pain duration, working alliance, acceptance, and adherence were evaluated. METHODS:Participants were recruited online and in collaboration with pain experts, and were randomized to interact with SELMA for 8 weeks either every day or every other day concerning CBT-based pain management (n=59), or weekly concerning content not related to pain management (n=43). Pain-related impairment (primary outcome), general well-being, pain intensity, and the bond scale of working alliance were measured at baseline and postintervention. Intention to change behavior and pain duration were measured at baseline only, and acceptance postintervention was assessed via self-reporting instruments. Adherence was assessed via usage data. RESULTS:From May 2018 to August 2018, 311 adults downloaded the SELMA app, 102 of whom consented to participate and met the inclusion criteria. The average age of the women (88/102, 86.4%) and men (14/102, 13.6%) participating was 43.7 (SD 12.7) years. Baseline group comparison did not differ with respect to any demographic or clinical variable. The intervention group reported no significant change in pain-related impairment (P=.68) compared to the control group postintervention. The intention to change behavior was positively related to pain-related impairment (P=.01) and pain intensity (P=.01). Working alliance with the TBHC SELMA was comparable to that obtained in guided internet therapies with human coaches. Participants enjoyed using the app, perceiving it as useful and easy to use. Participants of the intervention group replied with an average answer ratio of 0.71 (SD 0.20) to 200 (SD 58.45) conversations initiated by SELMA. Participants' comments revealed an appreciation of the empathic and responsible interaction with the TBHC SELMA. A main criticism was that there was no option to enter free text for the patients' own comments. CONCLUSIONS:SELMA is feasible, as revealed mainly by positive feedback and valuable suggestions for future revisions. For example, the participants' intention to change behavior or a more homogenous sample (eg, with a specific type of chronic pain) should be considered in further tailoring of SELMA. TRIAL REGISTRATION:German Clinical Trials Register DRKS00017147; https://tinyurl.com/vx6n6sx, Swiss National Clinical Trial Portal: SNCTP000002712; https://www.kofam.ch/de/studienportal/suche/70582/studie/46326.

SUBMITTER: Hauser-Ulrich S

PROVIDER: S-EPMC7165314 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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A Smartphone-Based Health Care Chatbot to Promote Self-Management of Chronic Pain (SELMA): Pilot Randomized Controlled Trial.

Hauser-Ulrich Sandra S Künzli Hansjörg H Meier-Peterhans Danielle D Kowatsch Tobias T

JMIR mHealth and uHealth 20200403 4

<h4>Background</h4>Ongoing pain is one of the most common diseases and has major physical, psychological, social, and economic impacts. A mobile health intervention utilizing a fully automated text-based health care chatbot (TBHC) may offer an innovative way not only to deliver coping strategies and psychoeducation for pain management but also to build a working alliance between a participant and the TBHC.<h4>Objective</h4>The objectives of this study are twofold: (1) to describe the design and ...[more]

PMID: 32242820

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Project description:BACKGROUND:Although mobile health (mHealth) interventions can help improve outcomes among patients with chronic lower back pain (CLBP), many available mHealth apps offer content that is not evidence based. Limbr was designed to enhance self-management of CLBP by packaging self-directed rehabilitation tutorial videos, visual self-report tools, remote health coach support, and activity tracking into a suite of mobile phone apps, including Your Activities of Daily Living, an image-based tool for quantifying pain-related disability. OBJECTIVE:The aim is to (1) describe patient engagement with the Limbr program, (2) describe patient-perceived utility of the Limbr program, and (3) assess the validity of the Your Activities of Daily Living module for quantifying functional status among patients with CLBP. METHODS:This was a single-arm trial utilizing a convenience sample of 93 adult patients with discogenic back pain who visited a single physiatrist from January 2016 to February 2017. Eligible patients were enrolled in 3-month physical therapy program and received the Limbr mobile phone app suite for iOS or Android. The program included three daily visual self-reports to assess pain, activity level, and medication/coping mechanisms; rehabilitation video tutorials; passive activity-level measurement; and chat-based health coaching. Patient characteristics, patient engagement, and perceived utility were analyzed descriptively. Associations between participant characteristics and program interaction were analyzed using multiple linear regression. Associations between Your Activities of Daily Living and Oswestry Disability Index (ODI) assessments were examined using Pearson correlation and hierarchical linear modeling. RESULTS:A total of 93 participants were enrolled; of these, 35 (38%) completed the program (age: mean 46, SD 16 years; female: 22/35, 63%). More than half of completers finished assessments at least every 3 days and 70% (19/27) used the rehabilitation component at least once a week. Among respondents to a Web-based feedback survey, 76% (16/21) found the daily notifications helped them remember to complete their exercises, 81% (17/21) found the system easy to use, and 62% (13/21) rated their overall experience good or excellent. Baseline Your Activities of Daily Living score was a significant predictor of baseline ODI score, with ODI increasing by 0.30 units for every 1-unit increase in Your Activities of Daily Living (P<.001). Similarly, hierarchical linear modeling analysis indicated that Your Activities of Daily Living daily assessment scores were significant predictors of ODI scores over the course of the study (P=.01). CONCLUSIONS:Engagement among participants who completed the Limbr program was high, and program utility was rated positively by most respondents. Your Activities of Daily Living was significantly associated with ODI scores, supporting the validity of this novel tool. Future studies should assess the effect of Limbr on clinical outcomes, evaluate its use among a wider patient sample, and explore strategies for reducing attrition. TRIAL REGISTRATION:ClinicalTrials.gov NCT03040310; https://clinicaltrials.gov/ct2/show/NCT03040310 (Archived by WebCite at http://www.webcitation.org/722mEvAiv).

Project description:BackgroundChronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed.ObjectiveThis feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain.MethodsThe EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire.ResultsParticipants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, "totally agree" or "agree"; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).Conclusions Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress.Trial registrationClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Project description:BackgroundChronic pain constitutes a significant burden for the individuals affected, and is a frequent reason why patients seek health care services. While in-person psychosocial interventions can be of support to people living with chronic pain, such interventions are not always accessible. eHealth interventions may provide greater accessibility, but the evidence and use of digital self-management solutions for chronic pain are still limited and the lack of health care provider input in the development process of such solutions a concern. Therefore, the aim of the current study was to investigate health care providers' experiences of treating patients with chronic pain, their attitudes towards, and use of, digital solutions in pain management, and their suggestions for content and design elements for a potential digital pain self-management intervention.MethodsTwelve health care providers representing a variety of health care disciplines participated in semi-structured interviews. The interviews were analyzed using thematic analysis.ResultsThe material was analyzed into three main themes: [1] Patients with chronic pain and their current use of the health care services, [2] Health care providers' own motivation and impression of patient prerequisites for use of digital self-management interventions, and [3] Suggestions for content and design elements in a digital self-management intervention for people living with chronic pain. The challenges faced by patients living with chronic pain were described as numerous. Despite interest and positive attitudes, few of the health care providers had used or recommended eHealth solutions to their patients. A range of potential content and functionality elements were identified, including aspects of motivation and engagement and providers also emphasized the importance of easy access and positive, personal content to support existing treatment.ConclusionsThis study offers insights into health care providers' considerations for the potential of digital self-management interventions supporting patients living with chronic pain. Findings indicate the need for change and a more comprehensive treatment approach to pain management. eHealth solutions may contribute to such change, and providers pointed to a need for health care provider involvement, timely support and follow-up as important factors for integrating digital pain self-management interventions into clinical care.Trial registrationClinicalTrials.gov : NCT03705104.

Project description:Fatigue is a common yet difficult to treat condition in primary care. The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy (CBT) based fatigue self-management (FSM) intervention as compared to usual care among patients with chronic fatigue in primary care.An economic evaluation alongside of a parallel randomized controlled study design was used. Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments. Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook, New York. The FSM group (n = 37) received two sessions of a nurse-delivered, fatigue self-management protocol and a self-help book and the usual care group (n = 36) received regular medical care. The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up. A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios (ICERs) and net monetary benefit (NMB) were calculated as measures of cost-effectiveness.The ICER for FSM was -$$2358, indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care. Complete case analysis yielded smaller ICER (-$1199) with greater uncertainties. Net monetary benefit analysis showed that FSM has a probability of 0.833 (95% CI: 0.819, 0.847) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs.This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months. The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care. Additional research is needed to examine the reproducibility and generalizability of these findings.ClinicalTrials.gov (NCT00997451, March 28, 2009).

Project description:BACKGROUND:Adolescence is a challenging period, where youth face rapid changes as well as increasing socioemotional demands and threats, such as bullying and cyberbullying. Adolescent mental health and well-being can be best supported by providing effective coaching on life skills, such as coping strategies and protective factors. Interventions that take advantage of online coaching by means of chatbots, deployed on Web or mobile technology, may be a novel and more appealing way to support positive mental health for adolescents. OBJECTIVE:In this pilot study, we co-designed and conducted a formative evaluation of an online, life skills coaching, chatbot intervention, inspired by the positive technology approach, to promote mental well-being in adolescence. METHODS:We co-designed the first life skills coaching session of the CRI (for girls) and CRIS (for boys) chatbot with 20 secondary school students in a participatory design workshop. We then conducted a formative evaluation of the entire intervention-eight sessions-with a convenience sample of 21 adolescents of both genders (mean age 14.52 years). Participants engaged with the chatbot sessions over 4 weeks and filled in an anonymous user experience questionnaire at the end of each session; responses were based on a 5-point Likert scale. RESULTS:A majority of the adolescents found the intervention useful (16/21, 76%), easy to use (19/21, 90%), and innovative (17/21, 81%). Most of the participants (15/21, 71%) liked, in particular, the video cartoons provided by the chatbot in the coaching sessions. They also thought that a session should last only 5-10 minutes (14/21, 66%) and said they would recommend the intervention to a friend (20/21, 95%). CONCLUSIONS:We have presented a novel and scalable self-help intervention to deliver life skills coaching to adolescents online that is appealing to this population. This intervention can support the promotion of coping skills and mental well-being among youth.

Project description:BACKGROUND:Patients with chronic pain often lack the skills and resources necessary to manage this disease. OBJECTIVE:To develop a chronic pain self-management program reflecting community stakeholders' priorities and to compare functional outcomes from training in two settings. DESIGN:A parallel-group randomized trial. PARTICIPANTS:Eligible subjects were 35-70 years of age, with chronic non-cancer pain treated with opioids for >2 months at two primary care and one HIV clinic serving low-income Hispanics. INTERVENTIONS:In one study arm, the 6-month program was delivered in monthly one-on-one clinic meetings by a community health worker (CHW) trained as a chronic pain health educator, and in the second arm, content experts gave eight group lectures in a nearby library. MAIN MEASURES:Five times Sit-to-Stand test (5XSTS) assessed at baseline and 3 and 6 months. Other reported physical and cognitive measures include the 6-Min Walk (6 MW), Borg Perceived Effort Test (Borg Effort), 50-ft Speed Walk (50FtSW), SF-12 Physical Component Summary (SF-12 PCS), Patient-Specific Functional Scale (PSFS), and Symbol-Digit Modalities Test (SDMT). Intention-to-treat (ITT) analyses in mixed-effects models adjust for demographics, body mass index, maximum pain, study arm, and measurement time. Multiple imputation was used for sensitivity analyses. KEY RESULTS:Among 111 subjects, 53 were in the clinic arm and 58 in the community arm. In ITT analyses at 6 months, subjects in both arms performed the 5XSTS test faster (-4.9 s, P =?0.001) and improved scores on Borg Effort (-1, P =?0.02), PSFS (1.6, P <?0.001), and SDMT (5.9, P?<?0.001). Only the clinic arm increased the 6 MW (172.4 ft, P?=?0.02) and SF-12 PCS (6.2 points, P?<?0.001). 50ftSW did not change (P =?0.15). Results were similar with multiple imputation. Five falls were possible adverse events. CONCLUSIONS:In low-income subjects with chronic pain, physical and cognitive function improved significantly after self-management training from expert lectures in the community and in-clinic meetings with a trained health educator.

Dataset Information

A Smartphone-Based Health Care Chatbot to Promote Self-Management of Chronic Pain (SELMA): Pilot Randomized Controlled Trial.

Publications

A Smartphone-Based Health Care Chatbot to Promote Self-Management of Chronic Pain (SELMA): Pilot Randomized Controlled Trial.

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